A.
Permit. A person shall not manufacture, package, repackage, label, or relabel
any narcotic or other controlled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regulated chemical without a
current Board-issued drug manufacturer permit.
B. Application. To obtain a permit to operate
a drug manufacturing firm in Arizona, a person shall submit a completed
application, on a form furnished by the Board, and the fee specified in
R4-23-205.
1.
Business name, address, mailing address, if
different, telephone number, and facsimile number;
2.
Owner's name, if corporation or partnership,
officers or partners, including address and title, and any other trade or
business names used;
3.
Whether the owner, corporation, or partnership has
conducted a similar business in any other jurisdiction and if so, indicate
under what name and location;
4.
Whether the owner, any officer, or active partner
has ever been convicted of an offense involving moral turpitude, a felony
offense, or any drug-related offense or has any currently pending felony or
drug-related charges, and if so, indicate charge, conviction date,
jurisdiction, and location;
5.
Whether the owner, any officer, or active partner
has ever been denied a drug manufacturer permit in this state or any other
jurisdiction, and if so, indicate where and when;
6.
A copy of the drug list required by the
FDA;
7.
Plans or construction drawings showing facility size
and security for the proposed business;
8.
Applicant's and manager's name, address, emergency
telephone number, and resumé indicating educational or experiential
qualifications related to drug manufacturer operation;
9.
The applicant's current FDA drug manufacturer or
repackager registration number and expiration date;
10.
Documentation of compliance with local zoning
laws;
11.
For an application submitted because of ownership
change, the former owner's name and business name, if
different;
12.
Date signed, and applicant's, corporate officer's,
partner's, or manager's verified signature and title; and
13.
Fee specified in
R4-23-205 .
C. Before issuing a drug
manufacturer permit, the Board shall:
1.
Receive and approve a completed permit application;
2. Interview the applicant and manager, if
different from the applicant, at a Board meeting; and
3. Receive a satisfactory compliance
inspection report on the facility from a Board compliance officer.
D. Notification. A resident drug
manufacturer permittee shall notify the Board of changes involving the drug
list, address, telephone number, business name, or manager, including manager's
telephone number. The resident drug manufacturer permittee shall submit using
the permittee's online profile or a written notice by mail, fax, or e-mail to
the the Board office within 24 hours of the change.
E. Change of ownership. A resident drug
manufacturer permittee shall comply with
R4-23-601(F).
F. Before an existing resident drug
manufacturer permittee relocates, the drug manufacturer permittee shall submit
the application packet described in subsection
R4-23-604(B),
excluding the fee. The facility at the new location shall pass a final
inspection by a Board compliance officer before operations begin.
G. No later than 14 days after the change
occurs, a resident drug manufacturer permittee shall submit the application
described under subsection
R4-23-604(B), excluding the fee, for any change of
officers in a corporation.
H.
Manufacturing and distribution.
1. A drug
manufacturer permittee shall manufacture and distribute a drug only:
a. To a pharmacy, drug manufacturer, or
full-service or nonprescription drug wholesaler currently permitted by the
Board;
b. To a medical practitioner
currently licensed as a medical practitioner as defined in A.R.S. §
32-1901;
or
c. To a properly permitted,
registered, licensed, or certified person or firm of another
jurisdiction.
2. Before
manufacturing and distributing a drug that is not listed on a drug
manufacturer's permit application, the drug manufacturer permittee shall send
to the Board office a written request to amend the permit application,
including documentation of FDA approval to manufacture the drug not listed on
the original permit application. If a request to amend a permit application
includes the documentation required in this subsection, the Board or its
designee shall approve the request to amend within 30 days of
receipt.
I. A drug
manufacturer permit is subject to denial, suspension, probation, or revocation
under A.R.S. §
32-1927.02.
J. Current Good Manufacturing Practice. A
drug manufacturer permittee is required under federal law to follow the good
manufacturing practice requirements of 21 CFR
210 through
211 www.gpo.gov.
K. Records. A drug manufacturer permittee
shall:
1. Establish and implement written
procedures for maintaining records pertaining to production, process control,
labeling, packaging, quality control, distribution, complaints, and any
information required by federal or state law;
2. Retain the records required by this
Article and 21 CFR
210 through
211 for at least two years after distribution of
a drug or one year after the expiration date of a drug, whichever is longer;
and
3. Make the records required by
this Article and 21 CFR
210 through
211 available within 48 hours for review by
a Board compliance officer or other authorized officer of the law as defined in
A.R.S. §
32-1901.
L. Inspections. A drug manufacturer permittee
shall make the drug manufacturer's facility available for inspection by the
Board or its compliance officer under A.R.S. §
32-1904.
M. Nonresident drug manufacturer. A
nonresident drug manufacturer shall comply with the requirements of
R4-23-607.
N. Manufacturing
radiopharmaceuticals. Before manufacturing a radiopharmaceutical, a drug
manufacturer permittee shall:
1. Comply with
the regulatory requirements of the Arizona Radiation Regulatory Agency, the
U.S. Nuclear Regulatory Commission, the FDA, and this Section; and
2. Hold a current Arizona Radiation
Regulatory Agency Radioactive Materials License. If a drug manufacturer
permittee who manufactures radiopharmaceuticals fails to maintain a current
Arizona Radiation Regulatory Agency Radioactive Materials License, the
permittee's drug manufacturer permit shall be immediately suspended pending a
hearing by the Board.
Notes
Ariz. Admin. Code §
R4-23-604
Former Rules 6.4001,
6.4002, 6.4003, 6.4004, 6.4005, 6.4006, 6.4007, 6.4008, 6.4009, 6.4100, 6.4110,
6.4111, 6.4115, 6.4116, 6.4120, 6.4122, 6.4190, 6.4191, 6.4200, 6.4250, 6.4300,
6.4350, 6.4355, 6.4360, 6.4400, 6.4401, 6.4403, 6.4410, 6.4430, 6.4450, 6.4500,
6.4510, 6.4530, 6.4533, 6.4600, 6.4610, 6.4640, 6.4660, 6.4700, 6.4710, and
6.4750. Adopted effective December 3, 1974 (Supp. 75-1). Amended effective
August 10, 1978 (Supp. 78-4). Amended subsection (B) paragraph (2) effective
April 20, 1982 (Supp. 82-2). Amended subsections (B), (G), (K) and (L)
effective August 12, 1988 (Supp. 88-3). Amended effective August 24, 1992
(Supp. 92-3). Amended effective November 1, 1993 (Supp. 93-4). Amended by final
rulemaking at 7 A.A.R. 3815, effective August 9, 2001 (Supp. 01-3). Amended by
final rulemaking at 11 A.A.R. 1105, effective April 30, 2005 (Supp. 05-1).
Amended by final rulemaking at 19 A.A.R. 702, effective June 1, 2013 (Supp.
13-2). Amended by final rulemaking at
25
A.A.R. 1015, effective 6/1/2019.
